BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE 20 ML BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 16317090 · Received February 7, 2023

    Report

    Report Number
    9610847-2023-00016
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056170
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-JAN-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 1 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE PHYSICAL SAMPLE SHOWED THAT THERE WAS A FOREIGN MATTER PARTICULATE ON THE RETURNED SAMPLE. FTIR TESTING WAS PERFORMED IN AN ATTEMPT TO DETERMINE THE COMPOSITION OF THE MATERIAL, BUT THE RESULT OF THE TEST WAS INCONCLUSIVE. SINCE THE FTIR RESULTS WERE INCONCLUSIVE, AND AN EXACT MATERIAL COMPOSITION COULD NOT BE DETERMINED, AN EXACT MANUFACTURING RELATED ROOT CAUSE COULD NOT BE DETERMINED. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MET OUR MANUFACTURING PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE 20 ML BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINANTS AS REPORTED BY OUR CUSTOMER. 20 ML, LOT # - 2123361.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE 20 ML BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINANTS AS REPORTED BY OUR CUSTOMER. 20 ML, LOT # - 2123361.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229409 BD LUER-LOK¿ SYRINGE 20 ML BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2123361 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown